CT Indexes of Emphysema and Airways in Healthy Volunteers: Normal Values; Relations With Gender, Height and Weight
19. november 2015 oppdatert av: Erasme University Hospital
Various indexes have been proposed to quantify both pulmonary emphysema and airways disease on chest CT scans.
It is unknown whether these indexes should be consider in absolute values or as compared to predicted normal values.
The purposes of the present study is thus : a) to measure these indexes at CT in healthy volunteers; b) to investigate their relations with gender, height and weight.
Studieoversikt
Detaljert beskrivelse
87 healthy volunteers performed consecutively a low-dose chest CT scan and pulmonary function tests:
On chest CT scans, indexes reflecting pulmonary emphysema and airways measurements have been computed by using dedicated softwares. Each of our three readers performed two reading sessions.
Relative area of lung parenchyma with attenuation value less than -960 Hounsfield Units; luminal area and wall thickness in third and fourth generations airways were recorded.
- Pulmonary function tests were performed: vital capacity, forced vital capacity , functional residual capacity, total lung capacity, residual volume, forced expiratory volume in one second, and diffusion lung capacity for carbon monoxide were recorded (either in absolute values and percentage of predicted values).
CT indexes were compared with gender, height and weight.
Studietype
Observasjonsmessig
Registrering (Faktiske)
87
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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Brussels, Belgia, 1070
- Erasme University Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Healthy Volunteers
Beskrivelse
Inclusion Criteria:
- Never smoked.
- No respiratory infection in the 4 weeks before the begin of the study.
- No history of pulmonary resection.
- No active malignancy or malignancy of any organ system within the past 5 years.
Exclusion Criteria:
- no exclusion criteria
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Healthy Volunteers
Inclusion criteria:
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Supine chest CT scan after full inspiration. Acquisition parameters: (Topogram 35 mA 120 kV 512 mm length) 35 quality ref mAs with care-dose ON 120 kV Pitch 1.4 Rotation time 0.33 s Acquired images 64 x 0.6 mm |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
CT index - RA960 (%)
Tidsramme: 4 hours
|
From acquired data, images were reconstructed using a soft algorithm.
On these soft images, the relative area of lung parenchyma with attenuation value less than -960 Hounsfield Units was computed (expressed in %), as an index representative of pulmonary emphysema extent.
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4 hours
|
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CT index - LA3rd (mm2)
Tidsramme: 4 hours
|
From acquired data, images were reconstructed using a high resolution algorithm.
On these high-resolution images, the airway lumen was measured in third generations of airways (expressed in mm2).
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4 hours
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CT index - LA4th (mm2)
Tidsramme: 4 hours
|
From acquired data, images were reconstructed using a high resolution algorithm.
On these high-resolution images, the airway lumen was measured in fourth generations of airways (expressed in mm2).
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4 hours
|
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CT index - WT3rd (mm)
Tidsramme: 4 hours
|
From acquired data, images were reconstructed using a high resolution algorithm.
On these high-resolution images, the airway wall was measured in third generations of airways (expressed in mm).
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4 hours
|
|
CT index - WT4th (mm)
Tidsramme: 4 hours
|
From acquired data, images were reconstructed using a high resolution algorithm.
On these high-resolution images, the airway wall was measured in fourth generations of airways (expressed in mm).
|
4 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pulmonary function tests - VC (l)
Tidsramme: 4 hours
|
Vital capacity was measured (expressed in l).
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4 hours
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|
Pulmonary function tests - FVC (l)
Tidsramme: 4 hours
|
Forced vital capacity was measured (expressed in l).
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4 hours
|
|
Pulmonary function tests - FRC (l)
Tidsramme: 4 hours
|
Functional residual capacity capacity was measured (expressed in l).
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4 hours
|
|
Pulmonary function tests - TLC (l)
Tidsramme: 4 hours
|
Total lung capacity was measured (expressed in l).
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4 hours
|
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Pulmonary function tests - RV (l)
Tidsramme: 4 hours
|
Residual volume was measured (expressed in l).
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4 hours
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Pulmonary function tests - FEV1 (l)
Tidsramme: 4 hours
|
Forced expiratory volume in one second was measured (expressed in l).
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4 hours
|
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Pulmonary function tests - DLCO (ml/min/ mmHg)
Tidsramme: 4 hours
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Diffusion lung capacity for carbon monoxide was measured (expressed in ml/min/ mmHg)
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4 hours
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Madani A, Zanen J, de Maertelaer V, Gevenois PA. Pulmonary emphysema: objective quantification at multi-detector row CT--comparison with macroscopic and microscopic morphometry. Radiology. 2006 Mar;238(3):1036-43. doi: 10.1148/radiol.2382042196. Epub 2006 Jan 19.
- Madani A, De Maertelaer V, Zanen J, Gevenois PA. Pulmonary emphysema: radiation dose and section thickness at multidetector CT quantification--comparison with macroscopic and microscopic morphometry. Radiology. 2007 Apr;243(1):250-7. doi: 10.1148/radiol.2431060194.
- Hackx M, Bankier AA, Gevenois PA. Chronic obstructive pulmonary disease: CT quantification of airways disease. Radiology. 2012 Oct;265(1):34-48. doi: 10.1148/radiol.12111270.
- Hackx M, Gyssels E, Severo Garcia T, De Meulder I, Alard S, Bruyneel M, Van Muylem A, Ninane V, Gevenois PA. Chronic Obstructive Pulmonary Disease: CT Quantification of Airway Dimensions, Numbers of Airways to Measure, and Effect of Bronchodilation. Radiology. 2015 Dec;277(3):853-62. doi: 10.1148/radiol.2015140949. Epub 2015 May 19.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2010
Primær fullføring (Faktiske)
1. juni 2011
Studiet fullført (Faktiske)
1. juni 2011
Datoer for studieregistrering
Først innsendt
30. oktober 2015
Først innsendt som oppfylte QC-kriteriene
19. november 2015
Først lagt ut (Anslag)
23. november 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. november 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. november 2015
Sist bekreftet
1. november 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P2010/175
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